A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.

NCT01986114 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2022-04-12

Study results available
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Summary

The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.

Conditions

Interventions

DRUG

SM-13496

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Director, Drug Development Division · Sumitomo Pharma Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-29
Primary Completion
2018-02-08
Completion
2018-02-17

Countries

  • Japan
  • Lithuania
  • Malaysia
  • Philippines
  • Russia
  • Slovakia
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01986114 on ClinicalTrials.gov